Metoprolol Tartrate
- Product NDC
- 0615-8016
- Requested package NDC
- 0615-8016-05
- 11-digit product format
- 006158016
- Labeler code
- 0615
- Product ID
- 0615-8016_e51b3b3f-5a8f-4dec-a83a-dda54bc8db24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metoprolol tartrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA076704
- Marketing category
- ANDA
- Marketing start
- 1993-12-23
- Marketing end
- 2023-11-30
- Substance
- METOPROLOL TARTRATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0615-8016 | 0615-8016-05 | D | Discontinued by firm | 2026-08-10 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076704-001 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | |
| A076704-002 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | |
| A076704-003 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 |
| A076704-004 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | |
| A076704-005 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076704-001 | AB |
| A076704-002 | AB |
| A076704-003 | AB |
| A076704-004 | AB |
| A076704-005 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076704-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076704-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076704-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076704-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076704-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2004-01-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2004-01-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | RS | 2004-01-16 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2015-03-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2015-03-18 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076704-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076704-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076704-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076704-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076704-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076704-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076704-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076704-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076704-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076704-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076704-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076704-005 | AB | 1 | 5bbf6a4d5a75… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metoprolol Tartrate | METOPROLOL TARTRATE | PD-Rx Pharmaceuticals, Inc. | cbcec1e7-7eac-456e-a253-aaf6761b4883 | 2026-08-05 | Warnings, Adverse reactions | 076704 ANDA076704 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Cardinal Health 107, LLC | 6399f2c3-7799-4f8b-b8b7-8d2137b1f852 | 2026-07-28 | Warnings, Adverse reactions | 076704 ANDA076704 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Cardinal Health 107, LLC | 0ccb9d3c-3f9a-486d-9b27-dc6f3ef6f4ed | 2026-07-10 | Warnings, Adverse reactions | 076704 ANDA076704 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Safecor Health, LLC | 63d45147-9b37-40e2-9619-cd1a3e77ff31 | 2026-07-10 | Warnings, Adverse reactions | 076704 ANDA076704 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | PD-Rx Pharmaceuticals, Inc. | ab44f4c5-9497-4c92-8545-e4718ddb8f08 | 2026-05-21 | Warnings, Adverse reactions | 076704 ANDA076704 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Mylan Institutional Inc. | 961248d5-d53c-408d-8f8f-d31885054f96 | 2025-07-22 | Warnings, Adverse reactions | 076704 ANDA076704 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Golden State Medical Supply, Inc. | bec7ccad-00ad-4a3b-e053-2995a90ae3d8 | 2024-03-18 | Warnings, Adverse reactions | 076704 ANDA076704 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Mylan Pharmaceuticals Inc. | 809c6386-0039-42ff-a03e-e42733e229b8 | 2024-01-31 | Warnings, Adverse reactions | 076704 ANDA076704 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | ea141b60-b08e-4f0f-9f29-cd765f4d7ca6 | 2022-03-10 | Warnings, Adverse reactions | 076704 ANDA076704 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0615-8016-05 | 00615801605 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8016-05) | 2016-04-08 | 2023-11-30 | No | No | Current |